Baseline demographics and MRI characteristics (intent-to-treat population)
| Characteristic | IFN β-1a, 44 µg subcutaneously three times a week (n=171) | IFN β-1a, 44 µg subcutaneously once a week (n=175) | Placebo (n=171) | Overall (N=517) |
|---|---|---|---|---|
| Age, years | ||||
| Mean (SD) | 30.6 (8.5) | 30.7 (8.1) | 30.9 (7.9) | 30.7 (8.2) |
| Median (Q1, Q3) | 29.0 (24.0, 36.0) | 30.0 (25.0, 37.0) | 29.0 (25.0. 37.0) | 29.0 (24.0, 37.0) |
| Female, n (%) | 114 (66.7) | 106 (60.6) | 112 (65.5) | 332 (64.2) |
| Classification of first clinical demyelinating event as monofocal,* n (%) | 96 (56.1) | 90 (51.4) | 91 (53.2) | 277 (53.6) |
| Steroid use at first clinical demyelinating event, n (%) | 121 (70.8) | 123 (70.3) | 121 (70.8) | 365 (70.6) |
| EDSS score | ||||
| Mean (SD) | 1.56 (0.81) | 1.56 (0.74) | 1.57 (0.76) | 1.56 (0.77) |
| Median (Q1, Q3) | 1.50 (1.00, 2.00) | 1.50 (1.00, 2.00) | 1.50 (1.00, 2.00) | 1.50 (1.00, 2.00) |
| Gd+ lesions | ||||
| Presence of at least 1 T1 Gd+ lesion, n (%) | 68 (39.8) | 72 (41.1) | 73 (42.7) | 213 (41.2) |
| T1 Gd+ lesions | ||||
| Mean (SD) | 1.3 (2.5) | 1.5 (3.5) | 1.2 (2.7) | 1.3 (2.9) |
| Median (Q1, Q3) | 0.0 (0.0, 2.0) | 0.0 (0.0, 1.0) | 0.0 (0.0, 1.0) | 0.0 (0.0, 1.0) |
| T1 Gd+ lesion volume, mm3 | ||||
| Mean (SD) | 156.54 (427.33) | 194.15 (593.66) | 193.68 (588.50) | 181.56 (541.68) |
| Median (Q1, Q3) | 0.00 (0.00, 91.60) | 0.00 (0.00, 91.60) | 0.00 (0.00, 120.20) | 0.00 (0.00, 94.40) |
| T1 hypointense lesions | ||||
| Mean (SD) | 5.7 (6.8) | 5.9 (7.5) | 5.7 (8.0) | 5.8 (7.4) |
| Median (Q1, Q3) | 4.0 (1.0, 8.0) | 3.0 (1.0, 7.0) | 3.0 (1.0, 8.0) | 3.0 (1.0, 8.0) |
| T1 hypointense lesion volume, mm3 | ||||
| Mean (SD) | 675.02 (1049.85) | 774.80 (1287.98) | 670.29 (1054.13) | 707.23 (1136.20) |
| Median (Q1, Q3) | 280.40 (51.50, 984.20) | 203.10 (42.90, 895.50) | 266.10 (17.10, 892.60) | 231.70 (40.10, 893.70) |
| T2 lesions | ||||
| Mean (SD) | 22.0 (18.8) | 23.6 (21.0) | 21.3 (20.2) | 22.3 (20.0) |
| Median (Q1, Q3) | 17.0 (9.0, 29.0) | 17.0 (8.0, 35.0) | 15.0 (7.0, 28.0) | 17.0 (8.0, 30.0) |
| ≥9 T2 lesions, n (%) | 129 (75.4) | 126 (72.0) | 122 (71.3) | 377 (72.9) |
| T2 lesion volume, mm3 | ||||
| Mean (SD) | 3110.53 (310.74) | 3853.12 (4716.71) | 3334.92 (3990.41) | 3436.11 (4083.90) |
| Median (Q1, Q3) | 2039.90 (755.30, 3876.70) | 2057.00 (675.20, 5722.20) | 1778.30 (695.20, 4208.50) | 1928.40 (709.50, 4240.00) |
| Normalised brain volume, cm3 | ||||
| Mean (SD) | 1536.2 (73.69) | 1537.3 (66.47) | 1543.6 (65.64) | 1539.0 (68.63) |
| Median (Q1, Q3) | 1538.57 (1491.70, 1597.36) | 1539.97 (1500.81, 1574.96) | 1547.60 (1497.16, 1589.08) | 1544.10 (1497.16, 1586.13) |
*According to the adjudication committee.
EDSS, Expanded Disability Status Scale; Gd+, gadolinium-enhancing; IFN, interferon.